Model Number 1221-32-150 |
Device Problems
Difficult to Insert (1316); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that while revising this patient¿s hip for dislocation, it was determined by trialing that patient would need a +4 10 degree liner.The appropriate liner was opened, a pinnacle altrx +4 10 degree 32mm x 50mm to match her cup size.The surgeon had a clean and clear view with no obstructions when placed the liner into the cup with the lip positioned posteriorly where surgeon wanted it.When surgeon impacted the liner, the posterior ard¿s would not seat.Surgeon took the liner out and made sure again nothing was blocking the liner from being able to seat, impacted it and same thing.They opened a different liner of the same size, positioned it appropriately, impacted it and it went right in.The surgeon considered that there was something wrong with the ard¿s in the first liner as it was very odd that it would not seat.The anterior ard¿s had seated fine.There was no surgical delay.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (nc search) was performed for the finished device 122132150, lot m0120u, and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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